# FDA recall D-0139-2020

> **Mylan Laboratories Limited (Sterile Products Division)** · Class II · drug recall initiated 2019-10-07.

## Product

Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for:  Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

## Reason for recall

Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0139-2020
- **Recalling firm:** Mylan Laboratories Limited (Sterile Products Division)
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-07
- **Report date:** 2019-10-16
- **Termination date:** 2023-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bangalore, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0139-2020

## Citation

> AI Analytics. FDA recall D-0139-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0139-2020. Source: US FDA. Licensed CC0.

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